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Software IVDs - ARTG 314912

Access comprehensive regulatory information for Software IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 314912 and sponsored by Biomerieux Australia Pty Ltd, manufactured by BioFire Diagnostics LLC in United States of America. The device registration started on February 28, 2019.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class I
ARTG 314912
Class I
Software IVDs
ARTG ID: 314912
Good Name: Biomerieux Australia Pty Ltd - Software IVDs
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Intended Purpose

Software that is supplied separately to an IVD medical device (e.g. FilmArray) but which is intended to operate or influence the IVD.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
314912
Start Date
February 28, 2019
Effective Date
February 28, 2019
Manufacturer
Country
United States of America
Address
515 Colorow Dr, Salt Lake City, Utah, 84108